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- Title
Personalised rehabilitation to improve return to work in patients with persistent spinal pain syndrome type II after spinal cord stimulation implantation: a study protocol for a 12-month randomised controlled trial-the OPERA study.
- Authors
Moens, Maarten; Goudman, Lisa; Van de Velde, Dominique; Godderis, Lode; Putman, Koen; Callens, Jonas; Lavreysen, Olivia; Ceulemans, Dries; Leysen, Laurence; OPERA consortium; Van Buyten, Jean-Pierre; Smet, Iris; Jerjir, Ali; Bryon, Bart; Plazier, Mark; Raymaekers, Vincent; Schelfout, Sam; Crombez, Erwin; Theys, Tom; Van Hoylandt, Anaïs
- Abstract
<bold>Background: </bold>For patients with therapy-refractory persistent spinal pain syndrome type II (PSPS-T2), spinal cord stimulation (SCS) may serve as an effective minimally invasive treatment. Despite the evidence that SCS can improve return to work (RTW), only 9.5 to 14% of patients implanted with SCS are effectively capable of returning to work. Thus, it seems that current post-operative interventions are not effective for achieving RTW after SCS implantation in clinical practice. The current objective is to examine whether a personalised biopsychosocial rehabilitation programme specifically targeting RTW alters the work ability in PSPS-T2 patients after SCS implantation compared to usual care.<bold>Methods: </bold>A two-arm, parallel-group multicentre randomised controlled trial will be conducted including 112 patients who will be randomised (1:1) to either (a) a personalised biopsychosocial RTW rehabilitation programme of 14 weeks or (b) a usual care arm, both with a follow-up period until 12 months after the intervention. The primary outcome is work ability. The secondary outcomes are work status and participation, pain intensity, health-related quality of life, physical activity and functional disability, functional capacities, sleep quality, kinesiophobia, self-management, anxiety, depression and healthcare expenditure.<bold>Discussion: </bold>Within the OPERA project, we propose a multidisciplinary personalised biopsychosocial rehabilitation programme specifically targeting RTW for patients implanted with SCS, to tackle the high socio-economic burden of patients that are not re-entering the labour market. The awareness is growing that the burden of PSPS-T2 on our society is expected to increase over time due to the annual increase of spinal surgeries. However, innovative and methodologically rigorous trials exploring the potential to decrease the socio-economic burden when patients initiate a trajectory with SCS are essentially lacking.<bold>Trial Registration: </bold>ClinicalTrials.gov NCT05269212. Registered on 7 March 2022.
- Subjects
SPINAL cord; RANDOMIZED controlled trials; CHRONIC pain; SLEEP quality; DEEP brain stimulation; RESEARCH protocols
- Publication
Trials, 2022, Vol 23, Issue 1, p1
- ISSN
1745-6215
- Publication type
journal article
- DOI
10.1186/s13063-022-06895-5